Dysfunction; EndocrineNCT03840824
Blood Spot Self-administered Test and Assay
An observational study of Dysfunction; Endocrine and Effects of Chemotherapy, run by University of Pennsylvania at 1 site in United States.
Trial summary
The current study will compare hormone levels of AMH, FSH and inhibin B in blood specimens collected by venipuncture and fingerstick in a sample of pre-menopausal women ages 18-45 years with normal menstrual cycles. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysfunction; Endocrine, Effects of Chemotherapy, Premature Ovarian Failure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The target population is 80 pre-menopausal women ages 18-45 years with normal menstrual cycles: Aim 1: Total 80 subjects: * 30 cancer survivors * 30 similar aged healthy controls * 20 late reproductive aged women Aim 2: Subset of 60 subjects: * 30 cancer survivors * 30 similar aged healthy controls
Who may be able to join
- Adult females
- Age between 18-45 years
- Premenopausal (defined as menses in the past 12 months)
- Postmenarchal
- Presence of an intact uterus and two ovaries
- Ability and willingness to comply with study protocol
Who cannot join
- Pregnancy within the previous 3 months
- Lactation within the previous 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, Reproductive Research Unit
Philadelphia, Pennsylvania, 19143
About this study
The current study will compare hormone levels of AMH, FSH and inhibin B in blood specimens collected by venipuncture and fingerstick in a sample of pre-menopausal women ages 18-45 years with normal menstrual cycles.
Read the detailed description
Recent advances in cancer diagnosis and treatment have led to greater survival rates in patients with malignancies. However, these life-saving treatments, especially alkylating agents, often lead to premature ovarian failure, infertility and related long-term health problems. It is difficult to predict whether, and the extent to which, patients will experience these problems. There are no early clinical signs of decreased fertility potential; even young women who maintain cyclic menses after therapy are at high risk of infertility, early menopause and related health problems. Preliminary studies suggest that several surrogate measures of fertility potential are different in cancer survivors compared with controls. These include follicle stimulating hormone (FSH), estradiol, anti-mullerian hormone (AMH) and inhibin B. Large longitudinal studies are needed to validate these measures with gold standard outcomes such as pregnancy rates, pregnancy outcomes and time to menopause. The main impediment to assessing the value of these markers and generating data that is useful to cancer survivors is the need for frequent and timed blood samples.
Daily or frequent trips to the clinical center are not practical and reduce the compliance of even the most motivated patients. The hypothesis that will be tested by this study is that blood spot assays can be developed that provide robust, personalized data for surrogate markers of reproductive function which can be used to assess reproductive potential in women; furthermore, bloodspots collected at home are an acceptable method for reproductive hormone measurement in women with and without a history of cancer. The current study will compare hormone levels of AMH, FSH and inhibin B in blood specimens collected by venipuncture and fingerstick in a sample of subjects.
- Keywords
- healthy, premenopausal, postmenarchal, chemotherapy, alkylating agent, alkylator, high dose cancer therapy, low dose cancer therapy
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Survivor | Pre-menopausal women who are cancer survivors ages 18-45 years with normal menstrual cycles. | |
| Similar aged healthy controls | Pre-menopausal, healthy women ages 18-45 years with normal menstrual cycles | |
| Late Reproductive Age | Pre-menopausal, healthy women of late reproductive age |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMH pg/mL in dried bloodspot vs serum samples
Serum AMH ELISA assay results will be compared to capillary blood sample AMH collected on filter paper and dried. Recovery of spiked ligands, sensitivity and specificity of the assays will be also assessed.
Measured: Day 1
Secondary outcomes (5)
Adequacy of subject's self-collected bloodspot sample vs. sample collected in clinic
A capillary blood sample from a finger-prick is applied to Whatman #903 filter paper, allowed to dry at room temperature for at least 4 hours, and then stored until analysis in the laboratory. Subjects willing to conduct a finger stick at home will collect an additional dried blood spot sample for secondary outcome measures. At home blood spot cards will be compared to those obtained in the office to determine adequacy of collection.
Measured: Day 1
Measures of user acceptability through subject report/feedback
Ease of use data reported by subject survey will be summarized to determine the overall acceptability of bloodspot collection and the potential for at- home use
Measured: Day 1
AMH pg/mL in cancer survivors vs. healthy control cohorts
AMH in dried blood spots vs. serum collected during the early follicular phase in 30 cancer survivors (15 exposed to low dose cancer therapy, 15 exposed to high dose cancer therapy) and 30 healthy similar aged controls will be compared using tests and multivariable linear regression
Measured: Day 1
FSH (mIU/mL) in dried bloodspot vs serum samples
Serum FSH ELISA assay results will be compared to FSH in a dried capillary blood sample applied to filter paper. Recovery of spiked ligands and sensitivity and specificity of the assays will be assessed.
Measured: Day 1
Inhibin B (pg/ml) in dried bloodspot vs serum samples
Serum Inhibin B ELISA assay results will be compared to capillary blood sample Inhibin B collected on filter paper and dried. Recovery of spiked ligands and sensitivity and specificity of the assays will be assessed.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study startOct 2010
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysfunction; EndocrineStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clarisa Gracia, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840824
- Sponsor's protocol ID
- 812735
- Status last verified
- Feb 2020
- First submitted
- 17 Mar 2015
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
McDade TW, Woodruff TK, Huang YY, Funk WE, Prewitt M, Kondapalli L, Gracia CR. Quantification of anti-Mullerian hormone (AMH) in dried blood spots: validation of a minimally invasive method for assessing ovarian reserve. Hum Reprod. 2012 Aug;27(8):2503-8. doi: 10.1093/humrep/des194. Epub 2012 Jun 6.
PubMed 22674205
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Spot Self-administered Test and Assay
- ClinicalTrials.gov ID
- NCT03840824
- Acronym / sponsor ID
- 812735
- Keywords
- healthy, premenopausal, postmenarchal, chemotherapy, alkylating agent, alkylator, high dose cancer therapy, low dose cancer therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study will compare hormone levels of AMH, FSH and inhibin B in blood specimens collected by venipuncture and fingerstick in a sample of pre-menopausal women ages 18-45 years with normal menstrual cycles.
Detailed description
Recent advances in cancer diagnosis and treatment have led to greater survival rates in patients with malignancies. However, these life-saving treatments, especially alkylating agents, often lead to premature ovarian failure, infertility and related long-term health problems. It is difficult to predict whether, and the extent to which, patients will experience these problems. There are no early clinical signs of decreased fertility potential; even young women who maintain cyclic menses after therapy are at high risk of infertility, early menopause and related health problems. Preliminary studies suggest that several surrogate measures of fertility potential are different in cancer survivors compared with controls. These include follicle stimulating hormone (FSH), estradiol, anti-mullerian hormone (AMH) and inhibin B. Large longitudinal studies are needed to validate these measures with gold standard outcomes such as pregnancy rates, pregnancy outcomes and time to menopause. The main impediment to assessing the value of these markers and generating data that is useful to cancer survivors is the need for frequent and timed blood samples.
Daily or frequent trips to the clinical center are not practical and reduce the compliance of even the most motivated patients. The hypothesis that will be tested by this study is that blood spot assays can be developed that provide robust, personalized data for surrogate markers of reproductive function which can be used to assess reproductive potential in women; furthermore, bloodspots collected at home are an acceptable method for reproductive hormone measurement in women with and without a history of cancer. The current study will compare hormone levels of AMH, FSH and inhibin B in blood specimens collected by venipuncture and fingerstick in a sample of subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cancer Survivor | – | –Pre-menopausal women who are cancer survivors ages 18-45 years with normal menstrual cycles. |
| Similar aged healthy controls | – | –Pre-menopausal, healthy women ages 18-45 years with normal menstrual cycles |
| Late Reproductive Age | – | –Pre-menopausal, healthy women of late reproductive age |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The target population is 80 pre-menopausal women ages 18-45 years with normal menstrual cycles: Aim 1: Total 80 subjects: * 30 cancer survivors * 30 similar aged healthy controls * 20 late reproductive aged women Aim 2: Subset of 60 subjects: * 30 cancer survivors * 30 similar aged healthy controls
Key inclusion criteria (6 listed)
- Adult females
- Age between 18-45 years
- Premenopausal (defined as menses in the past 12 months)
- Postmenarchal
- Presence of an intact uterus and two ovaries
Key exclusion criteria (2 listed)
- Pregnancy within the previous 3 months
- Lactation within the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AMH pg/mL in dried bloodspot vs serum samples
Time frame: Day 1
Serum AMH ELISA assay results will be compared to capillary blood sample AMH collected on filter paper and dried. Recovery of spiked ligands, sensitivity and specificity of the assays will be also assessed.
5 secondary outcomes
Adequacy of subject's self-collected bloodspot sample vs. sample collected in clinic
Time frame: Day 1
Measures of user acceptability through subject report/feedback
Time frame: Day 1
AMH pg/mL in cancer survivors vs. healthy control cohorts
Time frame: Day 1
FSH (mIU/mL) in dried bloodspot vs serum samples
Time frame: Day 1
Inhibin B (pg/ml) in dried bloodspot vs serum samples
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Background: PubMed 22674205McDade TW, Woodruff TK, Huang YY, Funk WE, Prewitt M, Kondapalli L, Gracia CR. Quantification of anti-Mullerian hormone (AMH) in dried blood spots: validation of a minimally invasive method for assessing ovarian reserve. Hum Reprod. 2012 Aug;27(8):2503-8. doi: 10.1093/humrep/des194. Epub 2012 Jun 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clarisa Gracia, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysfunction; Endocrine and Effects of Chemotherapy, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMH pg/mL in dried bloodspot vs serum samples (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03840824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.